Keratinocyte growth factor for the treatment of the acute respiratory distress syndrome (KARE): a randomised, double-blind, placebo-controlled phase 2 trial

<p>(<b>A</b>) Immunofluorescence signal for dystrophin is significantly reduced in the SSI heart (bottom left panel) compared with the immunofluorescent signal in the SHAM heart (upper left panel), and the SHAM+ALLN (upper right panel) and SSI+ALLN (bottom right panel) myocardium. (<b>B</b>) Protein levels of dystrophin in the SHAM, SSI, SHAM+ALLN and SSI+ALLN hearts were measured 24 h after the CLP procedure and were expressed in arbitrary units (AUs). α-Tubulin was used to determine equivalent loading conditions. The results (n = 6 per group) are representative of three different experiments. Scale bars indicate 50 μm.</p

Spinal Cord Injury and Pressure Ulcer Prevention: Using Functional Activity in Pressure Relief

Background. People with spinal cord injury (SCI) are at increased risk of pressure ulcers due to prolonged periods of sitting. Concordance with pressure relieving movements is poor amongst this population, and one potential alternative to improve this would be to integrate pressure relieving movements into everyday functional activities. Objectives. To investigate both the current pressure relieving behaviours of SCI individuals during computer use and the application of an ergonomically adapted computer-based activity to reduce interface pressure. Design. Observational and repeated measures design. Setting. Regional Spinal Cord Injury Unit. Participants. Fourteen subjects diagnosed with SCI (12 male, 2 female). Intervention.Comparing normal sitting to seated movements and induced forward reaching positions. Main Outcome Measures. Interface pressure measurements: dispersion index (DI), peak pressure index (PPI), and total contact area (CA). The angle of trunk tilt was also measured. Results. The majority of movements yielded less than 25% reduction in interface pressure compared to normal sitting. Reaching forward by 150% of arm length during an adapted computer activity significantly reduced DI (p<0.05), angle of trunk tilt (p<0.05), and PPI for both ischial tuberosity regions (p<0.001 ) compared to normal sitting. Conclusion. Reaching forward significantly redistributed pressure at the seating interface, as evidenced by the change in interface pressures compared to upright sitting

Baisakhi (1941)

BACKGROUND: Serious case reviews and research studies have indicated weaknesses in risk assessments conducted by child protection social workers. Social workers are adept at gathering information but struggle with analysis and assessment of risk. The Department for Education wants to know if the use of a structured decision-making tool can improve child protection assessments of risk. METHODS/DESIGN: This multi-site, cluster-randomised trial will assess the effectiveness of the Safeguarding Children Assessment and Analysis Framework (SAAF). This structured decision-making tool aims to improve social workers’ assessments of harm, of future risk and parents’ capacity to change. The comparison is management as usual. Inclusion criteria: Children’s Services Departments (CSDs) in England willing to make relevant teams available to be randomised, and willing to meet the trial’s training and data collection requirements. Exclusion criteria: CSDs where there were concerns about performance; where a major organisational restructuring was planned or under way; or where other risk assessment tools were in use. Six CSDs are participating in this study. Social workers in the experimental arm will receive 2 days training in SAAF together with a range of support materials, and access to limited telephone consultation post-training. The primary outcome is child maltreatment. This will be assessed using data collected nationally on two key performance indicators: the first is the number of children in a year who have been subject to a second Child Protection Plan (CPP); the second is the number of re-referrals of children because of related concerns about maltreatment. Secondary outcomes are: i) the quality of assessments judged against a schedule of quality criteria and ii) the relationship between the three assessments required by the structured decision-making tool (level of harm, risk of (re)abuse and prospects for successful intervention). DISCUSSION: This is the first study to examine the effectiveness of SAAF. It will contribute to a very limited literature on the contribution that structured decision-making tools can make to improving risk assessment and case planning in child protection and on what is involved in their effective implementation. TRIAL REGISTRATION: ISRCTN 45137562 15 July 2014

Indicators of pulmonary exacerbation in cystic fibrosis: A Delphi survey of patients and health professionals

Background: There is uncertainty about the most important indicators of pulmonary exacerbations in CF. Methods: Two parallel Delphi surveys in 13 CF centres (UK and Ireland). Delphi 1: 31 adults with CF, ≥ one exacerbation over 12 months. Delphi 2: 38 CF health professionals. Rounds 1 and 2 participants rated their level of agreement with statements relating to indicators of exacerbation; Round 3 participants rated the importance of statements which were subsequently placed in rank order. Results: Objective measurements were of higher importance to health professionals. Feelings of increased debility were rated most important by adults with CF. Conclusions: There were clear differences in perspectives between the two groups as to the most important indicators of an exacerbation. This highlights that CF health professionals should take more cognisance of specific signs and symptoms reported by adults with CF, especially since these may be a precursor to an exacerbation

Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol

Background/aims To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children. Methods Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6–12 years with myopia of −0.50 dioptres or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms. The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events. Conclusions The Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population. Trial registration number ISRCTN99883695 , NCT0369008